Injectable Ampoule Filler Sealer

Q: What is an Injectable Ampoule Filler Sealer?

An Injectable Ampoule Filler Sealer is a high-precision automatic machine designed for filling and sealing glass ampoules with sterile liquid or powder injectables. It integrates filling, nitrogen flushing (pre- and post-filling), pre-heating, and flame sealing in a single monobloc unit. The machine ensures cGMP, US FDA, and WHO compliance, making it ideal for pharmaceutical, biotech, veterinary, and cosmetic industries. Models range from single-head to eight-head configurations for different production scales.

Q: What are the available models and their production capacities?

We offer four standard models: AFS-1 (Single Head) — Up to 25 ampoules per minute (approx. 1,500/hour) AFS-2 (Two Heads) — Up to 50 ampoules per minute AFS-4 (Four Heads) — Up to 100 ampoules per minute AFS-8 (Eight Heads) — Up to 200 ampoules per minute (approx. 12,000/hour) Higher-speed custom models can reach up to 36,000 ampoules per hour. All models support ampoule sizes from 1ml to 30ml (depending on the model) with filling volumes from 0.5ml to 25ml and ±1% filling accuracy.

Q: How does the Injectable Ampoule Filler Sealer work?

The machine operates on the slant traveling principle for gentle handling and reduced glass breakage. Sterilized ampoules are loaded into the hopper and transferred via star wheels or racks. As they move, the machine performs these sequential steps: Pre-gassing with nitrogen Precise volumetric filling (using piston pumps) Post-gassing with nitrogen Neck pre-heating Flame sealing using LPG + Oxygen burners Safety features like ' No Ampoule – No Filling ' and ' No Ampoule – No Seal ' prevent wastage. Filled and sealed ampoules are collected automatically on a dead-tray system.

Q: Is Injectable Ampoule Filler Sealer cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Injectable Ampoule Filler Sealer complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

Q: Does Adinath International provide Injectable Ampoule Filler Sealer internationally?

Yes, Adinath International Injectable Ampoule Filler Sealer export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure .

Description

Injectable Ampoule Filler Sealer is a specialized machine designed for the precise filling and sealing of glass ampoules, primarily used in the pharmaceutical, biotech, cosmetic, and chemical industries. These machines ensure sterile, accurate, and efficient packaging of liquid or powder injectables in glass ampoules, adhering to stringent cGMP standards. Below is a detailed description based on available information:

- Nitrogen Flushing: Pre- and post-filling nitrogen injection to maintain sterility and prevent oxidation.
- Minimal Changeover: Quick format changes for ampoule sizes (1ml to 30ml) with minimal parts replacement, reducing downtime.
- Cooling System: Prevents overheating, extending machine lifespan.
- Safety and Hygiene: Equipped with laminar airflow, isolators, or safety cabinets to meet US FDA and EU GMP standards.
- Dead-Tray System: Ensures proper diversion of filled and sealed ampoules, reducing manual handling.

- Some models are designed for pre-sterile Type D closed-mouth ampoules, featuring an additional station to open the ampoule before filling and sealing.
- Customizable for specific ampoule sizes, filling volumes, and production needs.
- Designed to handle variations in ampoule neck dimensions, thickness, and ovality.
- Complies with cGMP, US FDA, and WHO standards, ensuring suitability for sterile injectable production.

- Flow meters for flame regulation.
- Tool-less format changes for ease of operation.
- Optional integration with upstream (e.g., washing, sterilization tunnels) and downstream (e.g., inspection, labeling) equipment for a complete production line.
- High-speed models can process up to 36,000 ampoules or vials per hour and handle both open and closed ampoules.

Salient Features of Injectable Ampoule Filler Sealer

Compact model as per cGMP standard.
Higher production output up to 12000 Ampoules per hour.
“No Ampoule – No Filling” system.
Machine equipped with pre-warming station.
Full accessibility allows easy maintenance.
Flow Meters for regulating flames easily.

All contact parts made from High Quality Stainless Steel 316L & Non-contact parts made from Stainless Steel 304.
Minimum change over parts from 1ml to 10ml ampoule size.
Ampoule neck centering during gas flushing and filling operations.
Possibility of nitrogen gas flushing before, during and after filling.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Injectable Ampoule Filler Sealer

Empty washed & sterilized ampoules loaded onto infeed hopper of the machine. From where it has been received to receiving rack through starwheel/cassette. The moving rack which moves horizontally collect one/two/four/eight ampoules from the receiving rack and transfer the ampoule to the machine in left to right in an inclined position. During ampoule movement Pre-gassing, Filling, Post Gassing, Pre-heating & Sealing Station perform filling and sealing operations. At the end duly filled and sealed ampoules get collected automatically onto collection tray of the machine. For detailed working process please explore Automatic Ampoule Filler Video in top right section of this page.

Technical Specification of Injectable Ampoule Filler Sealer

Model	AFS-1	AFS-2	AFS-4	AFS-8
No. of Head	Single	Two	Four	Eight
Syringes	One	Double	Four	Eight
Ampoule Sizes	1 ml to 30 ml	1 ml to 30 ml	1 ml to 20 ml	1 ml to 20 ml
Filling Speed	Up to 25 ampoules/minute	Up to 50 ampoules/minute	Up to 100 ampoules/minute	Up to 200 ampoules/minute
Filling Precision	± 1%	± 1%	± 1%	± 1%
Filling Pump	Piston Pump	Piston Pump	Piston Pump	Piston Pump
Burner Gas	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)
Nitrogen Arrangement	Before & After Filling	Before & After Filling	Before & After Filling	Before & After Filling
Number of Fill Nozzles	One	Two	Four	Eight
Number of Nitrogen Nozzles	Two	Four	Eight	Sixteen
Number of Sealing Burners	Two	Four	Eight	Sixteen
Power Required	0.5 H.P.	1 H.P.	1 H.P.	2 H.P.
Power Voltage	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System
Contact Parts	Made from Stainless Steel 316L	Made from Stainless Steel 316L	Made from Stainless Steel 316L	Made from Stainless Steel 316L
Overall Dimension	915mm (L) x 610mm (W) x 965mm (H) approx.	915mm (L) x 760mm (W) x 965mm (H) approx.	1200mm (L) x 1070mm (W) x 965mm (H) approx.	2200mm (L) x 1400mm (W) x 1100mm (H) approx.

* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.

Types of Ampoule Filling Machine

Automatic Ampoule Filling Sealing Machine

Laboratory Ampoule Filling Sealing Machine

Closed Ampoule Filling Machine

Open Mouth Ampoule Filling Machine

Onion Skin Ampoule Filling Machine

Single Head Ampoule Filling Machine

Double Head Ampoule Filling Machine

Four Head Ampoule Filling Machine

Six Head Ampoule Filling Machine

Eight Head Ampoule Filling Machine

Applications of Ampoule Filling Machine

Benefits of Injectable Ampoule Filler Sealer

High Precision: Ensures accurate dosing and sealing, critical for injectable pharmaceuticals.

Sterility: Nitrogen flushing and hygienic design minimize contamination risks.

Efficiency: High-speed models and automation reduce labor and increase output.

Versatility: Suitable for various ampoule types, sizes, and product forms (liquid, powder, gel).

Low Maintenance: Robust SS construction and easy-access design reduce downtime and maintenance costs.

Scalability: Models range from lab-scale (single-head) to high-speed production (eight- or twelve-head).

Key Features of Injectable Ampoule Filler Sealer

Purpose and Applications:
- Used to fill and seal glass ampoules (open-mouth or closed-mouth, typically 1ml to 30ml) with injectable liquids, powders, or other sterile products.
- Common applications include pharmaceuticals (e.g., parenteral drugs), veterinary medicines, agro-insecticides, and cosmetics.

Design and Construction:
- Built on a stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) frame with a matt finish for durability and compliance with cGMP standards.
- Monobloc design integrates filling and sealing operations in a single unit, ensuring compactness and efficiency.
- Features large openings at the bottom for easy cleaning and maintenance, with a pendant-type electrical control panel for safe and user-friendly operation.

Operational Process:
- Ampoule Loading: Sterilized ampoules are loaded into an in-feed hopper and transferred via a star wheel or cassette to a transport rack, handling 1, 2, 4, 6, or 8 ampoules per cycle depending on the machine’s head configuration.
- Pre-Gassing: Nitrogen flushing occurs before filling to ensure an inert environment and minimize contamination.
- Filling: Precise filling of liquids or powders (0.5ml to 25ml per dose) using mechanisms like piston pumps, servo-driven systems, or peristaltic pumps. Neck centering ensures accuracy during filling.
- Post-Gassing: Additional nitrogen flushing after filling to further protect the product.
- Pre-Heating and Sealing: Ampoules are warmed at a pre-heating station with low-pressure flames, followed by sealing using oxygen and LPG (propane) flames. Specially designed rollers rotate ampoules for uniform sealing.
- Collection: Filled and sealed ampoules are automatically collected on a tray or dead-tray system for further processing, with rejected ampoule tips ejected into a separate container.

Filling Mechanisms:
- Piston Pump: Common for high precision and volumetric dosing, suitable for various liquid viscosities.
- Servo-Driven: Offers adjustable filling volumes via PLC for enhanced accuracy.
- Peristaltic Pump: Ideal for sterile applications, minimizing cross-contamination.
- “No Ampoule, No Fill” and “No Ampoule, Machine Stop” systems prevent wastage and ensure operational safety.

Sealing Process:
- Utilizes controlled heat sealing technology with oxygen and LPG flames to create airtight seals, preventing contamination and ensuring product sterility.
- Safety valves and pressure reducers regulate gas flow, while a stainless steel hood channels fumes during heating.

Capacity and Speed:
- Available in single, two, four, six, eight, or twelve-head models, with production speeds ranging from 25 to 400 ampoules per minute, depending on the model (e.g., 1500 ampoules/hour for single-head lab-scale machines, up to 12,000 ampoules/hour for eight-head high-speed models).
- Suitable for small, medium, and large-scale production.

FAQ for Injectable Ampoule Filler Sealer

What is an Injectable Ampoule Filler Sealer?

An Injectable Ampoule Filler Sealer is a high-precision automatic machine designed for filling and sealing glass ampoules with sterile liquid or powder injectables. It integrates filling, nitrogen flushing (pre- and post-filling), pre-heating, and flame sealing in a single monobloc unit. The machine ensures cGMP, US FDA, and WHO compliance, making it ideal for pharmaceutical, biotech, veterinary, and cosmetic industries. Models range from single-head to eight-head configurations for different production scales.

What are the available models and their production capacities?

We offer four standard models:

AFS-1 (Single Head) — Up to 25 ampoules per minute (approx. 1,500/hour)
AFS-2 (Two Heads) — Up to 50 ampoules per minute
AFS-4 (Four Heads) — Up to 100 ampoules per minute
AFS-8 (Eight Heads) — Up to 200 ampoules per minute (approx. 12,000/hour)

Higher-speed custom models can reach up to 36,000 ampoules per hour. All models support ampoule sizes from 1ml to 30ml (depending on the model) with filling volumes from 0.5ml to 25ml and ±1% filling accuracy.

How does the Injectable Ampoule Filler Sealer work?

The machine operates on the slant traveling principle for gentle handling and reduced glass breakage. Sterilized ampoules are loaded into the hopper and transferred via star wheels or racks. As they move, the machine performs these sequential steps:

Pre-gassing with nitrogen
Precise volumetric filling (using piston pumps)
Post-gassing with nitrogen
Neck pre-heating
Flame sealing using LPG + Oxygen burners

Safety features like “No Ampoule – No Filling” and “No Ampoule – No Seal” prevent wastage. Filled and sealed ampoules are collected automatically on a dead-tray system.

What key features ensure sterility and product quality?

The machine includes several advanced features for sterility and quality:

Nitrogen flushing before, during, and after filling to prevent oxidation and maintain an inert atmosphere
Laminar airflow / isolator compatibility for cleanroom operation
All product contact parts made of SS 316L
Tool-less quick changeover with minimal parts
Neck centering during flushing and filling
Cooling system to prevent overheating
PLC/HMI and servo-driven options for precise control

These ensure minimal contamination risk, accurate dosing, and long-term product stability.

What industries is the Injectable Ampoule Filler Sealer suitable for, and what are its main benefits?

It is widely used in:

Pharmaceuticals (parenteral/injectable drugs)
Biotech
Cosmetics
Veterinary medicines
Chemical and agro-insecticide industries

Main benefits include:

High filling accuracy (±1%)
Reduced product wastage
Quick format changeover and low maintenance
Full cGMP compliance with easy cleaning and validation
Compact footprint with high output
Minimal human intervention for enhanced sterility

The machine can be integrated into complete lines with washing, sterilization, inspection, and labeling equipment.

Is Injectable Ampoule Filler Sealer cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Injectable Ampoule Filler Sealer complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

What is the lead time for Injectable Ampoule Filler Sealer?

Manufacturing lead time is generally 7 to 14 weeks from order confirmation. Further it takes 2 to 8 weeks for international shipping depending upon destination. Order can be expediate sooner or later as per specific buying requirements. Destination specific certifications like US FDA, EU, ANVISA, SFDA. CE can add 3 to 6 weeks additionally.

Does Adinath International provide Injectable Ampoule Filler Sealer internationally?

Yes, Adinath International Injectable Ampoule Filler Sealer export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure.

Does After Sales Support provided for Injectable Ampoule Filler Sealer?

Service of skilled engineers and technicians provided for technical support of supplied equipments. Installations, commissioning, training and IQ, OQ, DQ validations performed by qualified engineers. Remote support through video call, phone, email and other modes provided for international installations. Spare parts of Injectable Ampoule Filler Sealer stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.